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This template shows all ODM v2.0 elements and attributes, including those that are optional. XML files would typically not include attributes with an empty string as value. Empty elements can sometimes have meaning. For example, An empty MethodSignature may be used to explicitly indicate that the method does not take any input parameters or return any values.

Attributes and elements within the <xhtml:div> element are not displayed in this template.

Code Block
languagexml
themeConfluence
titleTemplatelinenumberstrueODM v2.0 Template
<?xml version="1.0" encoding="UTF-8"?>
<ODM 
	xmlns:ds    xmlns="http://www.w3cdisc.org/2000ns/09odm/xmldsig#v2.0" 
	    xmlns:xsixhtml="http://www.w3.org/20011999/XMLSchema-instancexhtml" 
    xmlns:xlink="http://www.w3.org/1999/xlink"
	xmlns    xmlns:xsi="http://www.cdiscw3.org/ns/odm/v2.0" 
	xsi:schemaLocation=""
	2001/XMLSchema-instance"
    FileType="" 
	    Granularity="" 
	    Context="" 
	    FileOID=""
	    CreationDateTime="20212023-05-13"
	08-23T00:00:00" 
    PriorFileOID="" 
	    AsOfDateTime="2023-08-23T00:00:00"
	    ODMVersion="2.0-R1" 
	    Originator="CDISC Data Exchange Standards ODM v2.0 Team - Template Authored by Mike Hamidi" 	 
	" 
    SourceSystem=""
    
	SourceSystemVersion="">
	Description="CDISC  ODM v2.0 Template" 
	ID="">
	<Study OID="" StudyName <Description>
        <TranslatedText xml:lang="" ProtocolNameType="">
		<Description>
			<TranslatedText></TranslatedText>
		</Description>
		<MetaDataVersion            <xhtml:div>CDISC ODM v2.0 Template</xhtml:div>
        </TranslatedText>
    </Description>
    <Study OID="" NameStudyName="" CommentOIDProtocolName="">
			<Description>
					<TranslatedText xml:lang VersionId="" typeVersionName=""></TranslatedText>
			</Description>
			<Include StudyOID Status="" MetaDataVersionOID="" href=""/>
			<Protocol>
				<Description>
					>
        <Description>
            <TranslatedText xml:lang="" typeType=""></TranslatedText>
				</Description>
				<Alias Context>
                <xhtml:div> </xhtml:div>
            </TranslatedText>
        </Description>
        <MetaDataVersion OID="" Name="" CommentOID=""/>
				<StudyStructure>
					<Description>
						>
            <Description>
                <TranslatedText xml:lang="" typeType=""></TranslatedText>
					</Description>
					<Arm OID="" Name="">
							<Description>
								<TranslatedText xml:lang="" type=""></TranslatedText>
							</Description>
							<WorkflowRef WorkflowOID=""/>
					</Arm>
					<Epoch>
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Description>
            <Include StudyOID="" MetaDataVersionOID="" href=""> </Include>
            <Standards>
                <Standard OID="" Name="" Type="" PublishingSet="" Version="" SequenceNumberStatus="Draft" PlannedDurationCommentOID="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
					</Epoch>
					<WorkflowRef WorkflowOID=""/>
				</StudyStructure>
				<StudySummary>
				<!-- Draft Note 5/13/2021: Created https://jira.cdisc.org/browse/ODM2DEV-78 due to a reference to StudyParameters under https://wiki.cdisc.org/display/ODM2/ParameterValue which is not represented in the ODM v2.0 specification-->
					<StudyParameter OID="" Term="" ShortName="">
						<ParameterValue Value="">
							<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
						</ParameterValue>
					</StudyParameter>
				</StudySummary>
				<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
				</StudyEventGroupRef>		
				<StudyTiming OID="" Name="">
					<TransitionTimingConstraint OID="" Name="" TransitionOID="" TimepointTarget="" MethodOID="" TimepointPreWindow="" TimepointPostWindow="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
					</TransitionTimingConstraint> 
					<AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID="" StudyEventOID="" TimepointTarget="" TimepointPreWindow="" TimepointPostWindow="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
					</AbsoluteTimingConstraint> 	
					<DurationTimingConstraint OID="" Name="" StruturalElementOID="" DurationTarget="" DurationPreWindow=""/>
					<RelativeTimingConstraint OID="" Name="" PredecessorOID="" SuccessorOID="" RelativeTimepointTarget="" Type="" TimepointPreWindow="" TimepointPostWindow="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
					</RelativeTimingConstraint> 
				</StudyTiming>
			</Protocol>
			<WorkflowDef OID="" Name="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>	
				<WorkflowStart StartOID=""/>
				<Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID="" EndConditionOID=""/>
				<Branching OID="" Name="" Type="">
					<TargetTransition TargetTransitionOID="" ConditionOID=""/>
					<DefaultTransition TargetTransitionOID=""/>
				</Branching>
				<WorkflowEnd EndOID=""/>
			</WorkflowDef>
			<StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<StudyEventGroupRef StudyEventGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<StudyEventRef StudyEventOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
			</StudyEventGroupDef>
			<StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
			</StudyEventDef>
			<ItemGroupDef OID="" Name="" Repeating="" IsReferenceData="" DatasetName="" Domain="" Type="" Purpose="" CommentOID="" MethodOID="">
				<Description>
					 </Standard>
            </Standards>
            <AnnotatedCRF>
                <DocumentRef LeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
                </DocumentRef>
            </AnnotatedCRF>
            <SupplementalDoc>
                <DocumentRef LeafID="">
                    <PDFPageRef PageRefs="" FirstPage="" LastPage="" Type="" Title=""/>
                </DocumentRef>
            </SupplementalDoc>
            <ValueListDef OID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
                    UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
                    Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
                    <Origin Type="" Source=""> </Origin>
                    <WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
                </ItemRef>
            </ValueListDef>
            <WhereClauseDef OID="" CommentOID="">
                <RangeCheck Comparator="" SoftHard="" ItemOID="">
                    <CheckValue/>
                    <!-- 
                    <MethodSignature> </MethodSignature>
                    <FormalExpression Context="">
                        <Code></Code>
                    </FormalExpression>
                    -->
                    <ErrorMessage>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </ErrorMessage>
                </RangeCheck>
            </WhereClauseDef>
            <Protocol>
                <Description>
                    <TranslatedText xml:lang="" typeType=""><> </TranslatedText>
				                </Description>
				<Alias Context="" Name=""/>
				<ItemGroupRef ItemGroupOID="" Mandatory="" OrderNumber="" CollectionExceptionConditionOID=""/>
				<ItemRef ItemOID="" Mandatory="" OrderNumber="" KeySequence="" MethodOID="" UnitsItemOID="" Role="" RoleCodeListOID="" CollectionExceptionConditionOID="">
					<Origin Type="" SourceType="">
						<Description>
							<TranslatedText xml:lang="" type=""></TranslatedText>
						</Description>
						<Source>
							<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
								<Resource Type="" Name="" Attribute="">
									<Selection Path=""/>
								</Resource>
							</SourceItem>
						</Source>
					</Origin>
				</ItemRef>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Origin Type="" SourceType="">
					<Description>
						<TranslatedText xml:lang="" type=""></TranslatedText>
					</Description>
					<Source>
						<SourceItem ItemOID="" ItemGroupOID="" leafID="" Label="">
							<Resource Type="" Name="" Attribute="">
								<Selection Path=""/>
							</Resource>
						</SourceItem>
					</Source>
				</Origin>
			</ItemGroupDef>
			<ItemDef OID="" Name="" DataType="" Length="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<WorkflowRef WorkflowOID=""/>
				<Question> 
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Question>
				<RangeCheck Comparator="" SoftHard="" ItemOID="">
					<CheckValue></CheckValue>
					<ErrorMessage>
						<TranslatedText xml:lang="" type=""></TranslatedText>
					</ErrorMessage>
					<MethodSignature>
						<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
						<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
							<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
							<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
							<!-- Repeating -->
							</ReturnValue>
						</ReturnValue>
					</MethodSignature>
					<FormalExpression Context="">
						<Code></Code>
						<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
					</FormalExpression>
				</RangeCheck>
				<CodeListRef CodeListOID=""/>
			</ItemDef>
			<CodeList OID="" Name="" DataType="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				<CodeListItem CodedValue="" Rank="" OrderNumber="" CommentOID=""> 
					<Decode>
						<TranslatedText xml:lang="" type=""></TranslatedText>
					</Decode>
					<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
					<Alias Context="" Name=""/>
				</CodeListItem>
				<EnumeratedItem CodedValue="" Rank="" OrderNumber="" CommentOID=""> 
					<Alias Context="" Name=""/>
					<Coding Code="" System="" SystemName="" SystemVersion="" href="" CommentOID=""/>
				</EnumeratedItem>
				<!-- Draft Note: Create https://jira.cdisc.org/browse/ODM2DEV-80 to recommend adding a CommentOID attribute to ExternalCodeList -->
				<ExternalCodeList Dictionary="" Version="" ref="" href=""/>
			</CodeList>
			<MethodDef OID="" Name="" Type="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<MethodSignature>
					<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
					<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
						<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
						<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
						<!-- Repeating -->
						</ReturnValue>
					</ReturnValue>
				</MethodSignature>
				<FormalExpression Context="">
					<Code></Code>
					<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
				</FormalExpression>
			</MethodDef>
			<ConditionDef OID="" Name="" CommentOID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
				<Alias Context="" Name=""/>
				<MethodSignature>
					<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
					<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
						<Parameter Name="" DataType="" Definition="" OrderNumber=""/>
						<ReturnValue Name="" DataType="" Definition="" OrderNumber="">
						<!-- Repeating -->
						</ReturnValue>
					</ReturnValue>
				</MethodSignature>
				<FormalExpression Context="">
					<Code></Code>
					<ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
				</FormalExpression>
			</ConditionDef>
			<CommentDef OID="">
				<Description>
					<TranslatedText xml:lang="" type=""></TranslatedText>
				</Description>
			</CommentDef>
		</MetaDataVersion>
    </Study>   
	<AdminData StudyOID="">
		<User OID="" UserType="" OrganizationOID="" LocationOID="">
			<UserName></UserName>
			<Prefix></Prefix>
			<Suffix></Suffix>
			<FullName></FullName>
			<GivenName></GivenName>
			<FamilyName></FamilyName>
			<Image ImageFileName="" href="" MimeType=""/>
			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
		</User>
		<Location OID="" Name="" Role="" OrganizationOID="">
			<Description>
				<TranslatedText xml:lang="" type=""></TranslatedText>
			</Description>
			<MetaDataVersionRef StudyOID="" MetaDataVersionOID="" EffectiveDate=""/>
			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
			<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
				<Value SeqNum=""></Value>
				<AuditRecord EditPoint="" UsedMethod="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</AuditRecord>
			</Query>
		</Location>
		<Organization OID="" Name="" Type="" LocationOID="" PartOfOrganizationOID="">
			<Description>
				<TranslatedText xml:lang="" type=""></TranslatedText>
			</Description>	
			<Address>
				<HouseNumber></HouseNumber>
				<StreetName></StreetName>
				<City></City>
				<StateProv></StateProv>
				<Country></Country>				
				<PostalCode></PostalCode>
				<OtherText></OtherText>		
				<GeoPosition Longitude="" Latitude="" Altitude=""/>	
			</Address>
			<Telecom TelecomType="" Value=""/>
		</Organization>
		<SignatureDef OID="" Methodology="">
			<Meaning></Meaning>	
			<LegalReason></LegalReason>	
		</SignatureDef>
	</AdminData>
	<ReferenceData StudyOID="" MetaDataVersionOID="">
		<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
			<AuditRecord EditPoint="" UsedMethod="">
				<DateTimeStamp></DateTimeStamp>
				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</AuditRecord>
			<Signature>
				<SignatureRef SignatureOID=""/>
				<DateTimeStamp></DateTimeStamp>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</Signature>		
			<Annotation SeqNum="" TransactionType="">
				<Comment></Comment>
				<Flag> 
					<FlagValue CodeListOID=""/>
					<FlagType CodeListOID=""/>
				</Flag>
			</Annotation>
			<ItemData ItemOID="" TransactionType="" IsNull="">
				<Value SeqNum=""></Value>
				<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
					<Value SeqNum=""></Value>
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</AuditRecord>
				</Query>
				<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
				</AuditRecord>
				<Signature>
					<SignatureRef SignatureOID=""/>
					<DateTimeStamp></DateTimeStamp>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
				</Signature>	
				<Annotation SeqNum="" TransactionType="">
					<Comment></Comment>
					<Flag> 
						<FlagValue CodeListOID=""/>
						<FlagType CodeListOID=""/>
					</Flag>
				</Annotation>
			</ItemData>  
			                <StudySummary>
                    <StudyParameter OID="" Term="" ShortName="">
                        <ParameterValue Value="">
                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
                        </ParameterValue>
                    </StudyParameter>
                </StudySummary>
                <StudyStructure>
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                    <Arm OID="" Name="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""/>
                        </Description>
                        <WorkflowRef WorkflowOID=""/>
                    </Arm>
                    <Epoch OID="" Name="" SequenceNumber="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""/>
                        </Description>
                    </Epoch>
                    <WorkflowRef WorkflowOID=""> </WorkflowRef>
                </StudyStructure>
                <TrialPhase Value="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                </TrialPhase>
                <StudyTimings>
                    <StudyTiming OID="" Name="">
                        <AbsoluteTimingConstraint OID="" Name="" StudyEventGroupOID=""
                            StudyEventOID="" TimepointTarget="" TimepointPreWindow=""
                            TimepointPostWindow=""/>
                        <RelativeTimingConstraint OID="" Name="" Type="" PredecessorOID=""
                            SuccessorOID="" TimepointRelativeTarget="" TimepointPreWindow=""
                            TimepointPostWindow=""/>
                        <TransitionTimingConstraint OID="" Name="" TransitionOID="" MethodOID=""
                            Type="" TimepointPostWindow="" TimepointPreWindow="" TimepointTarget=""/>
                        <DurationTimingConstraint OID="" Name="" DurationPostWindow=""
                            DurationPreWindow="" DurationTarget="" StructuralElementOID=""/>
                    </StudyTiming>
                </StudyTimings>
                <StudyIndications>
                    <StudyIndication OID="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
                    </StudyIndication>
                </StudyIndications>
                <StudyInterventions>
                    <StudyIntervention OID="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""/>
                    </StudyIntervention>
                </StudyInterventions>
                <StudyObjectives>
                    <StudyObjective OID="" Name="" Type="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
                    </StudyObjective>
                </StudyObjectives>
                <StudyEndPoints>
                    <StudyEndPoint OID="" Name="" Type="" Level="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""> </TranslatedText>
                        </Description>
                        <FormalExpression Context="">
                            <Code/>
                            <!--                        
                            <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        -->
                        </FormalExpression>
                    </StudyEndPoint>
                </StudyEndPoints>
                <StudyTargetPopulation OID="" Name="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <FormalExpression Context="">
                        <Code/>
                        <!--                        
                            <ExternalCodeLib Library="" Method="" Version="" ref="" href=""/>
                        -->
                    </FormalExpression>
                </StudyTargetPopulation>
                <StudyEstimands>
                    <StudyEstimand OID="" Name="">
                        <Description>
                            <TranslatedText xml:lang="" Type=""/>
                        </Description>
                        <StudyTargetPopulationRef StudyTargetPopulationOID=""/>
                        <StudyInterventionRef StudyInterventionOID=""/>
                        <StudyEndPointRef StudyEndPointOID="" OrderNumber=""/>
                        <IntercurrentEvent>
                            <Description>
                                <TranslatedText xml:lang="" Type=""/>
                            </Description>
                        </IntercurrentEvent>
                        <SummaryMeasure>
                            <Description>
                                <TranslatedText xml:lang="" Type=""/>
                            </Description>
                        </SummaryMeasure>
                    </StudyEstimand>
                </StudyEstimands>
                <InclusionExclusionCriteria>
                    <InclusionCriteria>
                        <Criterion OID="" Name="" ConditionOID=""> 
                            <Description>
                                <TranslatedText xml:lang="" Type=""/>
                            </Description>
                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                        </Criterion>
                    </InclusionCriteria>
                    <ExclusionCriteria>
                        <Criterion OID="" Name="" ConditionOID=""> 
                            <Description>
                                <TranslatedText xml:lang="" Type=""/>
                            </Description>
                            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                       </Criterion>
                     </ExclusionCriteria>
                </InclusionExclusionCriteria>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                </StudyEventGroupRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Alias Context="" Name=""> </Alias>
            </Protocol>
            <WorkflowDef OID="" Name="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <WorkflowStart StartOID=""> </WorkflowStart>
                <Transition OID="" Name="" SourceOID="" TargetOID="" StartConditionOID=""
                    EndConditionOID=""> </Transition>
                <Branching OID="" Name="" Type="">
                    <TargetTransition TargetTransitionOID="" ConditionOID=""> </TargetTransition>
                    <DefaultTransition TargetTransitionOID=""> </DefaultTransition>
                </Branching>
                <WorkflowEnd EndOID=""/>
            </WorkflowDef>
            <StudyEventGroupDef OID="" Name="" ArmOID="" EpochOID="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <StudyEventGroupRef StudyEventGroupOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                </StudyEventGroupRef>
                <StudyEventRef StudyEventOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </StudyEventRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            </StudyEventGroupDef>
            <StudyEventDef OID="" Name="" Repeating="" Type="" Category="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </ItemGroupRef>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <Alias Context="" Name=""> </Alias>
            </StudyEventDef>
            <ItemGroupDef OID="" Name="" Repeating="" RepeatingLimit="" IsReferenceData=""
                Structure="" ArchiveLocationID="" DatasetName="" Domain="" Type="" Purpose=""
                StandardOID="" IsNonStandard="" HasNoData="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <Class Name="">
                    <SubClass Name="" ParentClass=""/>
                </Class>
                <ItemGroupRef ItemGroupOID="" MethodOID="" OrderNumber="" Mandatory=""
                    CollectionExceptionConditionOID=""> </ItemGroupRef>
                <ItemRef ItemOID="" KeySequence="" IsNonStandard="" HasNoData="" MethodOID=""
                    UnitsItemOID="" Repeat="" Other="" Role="" RoleCodeListOID="" OrderNumber=""
                    Mandatory="" CollectionExceptionConditionOID="" PreSpecifiedValue="" Core="">
                    <Origin Type="" Source=""> </Origin>
                    <WhereClauseRef WhereClauseOID=""> </WhereClauseRef>
                </ItemRef>
                <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                <WorkflowRef WorkflowOID=""> </WorkflowRef>
                <Origin Type="" Source="">
                    <Description>
                        <TranslatedText xml:lang="" Type=""> </TranslatedText>
                    </Description>
                    <SourceItems>
                        <SourceItem ItemOID="" ItemGroupOID="" MetaDataVersionOID="" StudyOID=""
                            LeafID="" Name="">
                            <Resource Type="" Name="" Attribute="" Label="">
                                <Selection Path=""/>
                            </Resource>
                        </SourceItem>
                    </SourceItems>
                    <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
                    <DocumentRef LeafID=""> </DocumentRef>
                </Origin>
                <Alias Context="" Name=""> </Alias>
                <Leaf ID="" xlink:href="">
                    <Title> </Title>
                </Leaf>
            </ItemGroupDef>
            <ItemDef OID="" Name="" DataType="" Length="" DisplayFormat="" CommentOID="">
                <Description>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
                </Description>
                <Question>
                    <TranslatedText xml:lang="" Type=""> </TranslatedText>
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				<AuditRecord EditPoint="" UsedMethod="">
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					<LocationRef LocationOID=""/>
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		State="" LastUpdateDatetime="" Name="">
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		<SubjectData SubjectKey="" TransactionType="">
			<AuditRecord EditPoint="" UsedImputationMethod="" ID="">
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				<ReasonForChange></ReasonForChange>
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				<LocationRef LocationOID=""/>
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				                <Comment SponsorOrSite=""> 
					
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				<Value SeqNum href=""></Value>
				<AuditRecord EditPoint ref="" UsedMethodCommentOID="">
					<DateTimeStamp></DateTimeStamp>
					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
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					<LocationRef LocationOID=""/>
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			<SiteRef LocationOID=""/>
			<StudyEventData StudyEventOID="" StudyEventRepeatKey="" TransactionType="">
				<ItemGroupData ItemGroupOID="" ItemGroupRepeatKey="" TransactionType="" ItemGroupDataSeq="">
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
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						<DateTimeStamp></DateTimeStamp>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
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					<Annotation SeqNum="" TransactionType="">
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							<AuditRecord EditPoint="" UsedMethod="">
								<DateTimeStamp></DateTimeStamp>
								<ReasonForChange></ReasonForChange>
								<SourceID></SourceID>
								<UserRef UserOID=""/>
								<LocationRef LocationOID=""/>
							</AuditRecord>
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						<AuditRecord EditPoint="" UsedMethod="">
								<DateTimeStamp></DateTimeStamp>
								<ReasonForChange></ReasonForChange>
								<SourceID></SourceID>
								<UserRef UserOID=""/>
								<LocationRef LocationOID=""/>
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						<Signature>
							<SignatureRef SignatureOID=""/>
							<DateTimeStamp></DateTimeStamp>
							<UserRef UserOID=""/>
							<LocationRef LocationOID=""/>
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						<Annotation SeqNum="" TransactionType="">
							<Comment></Comment>
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					<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
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						<AuditRecord EditPoint="" UsedMethod="">
							<DateTimeStamp></DateTimeStamp>
							<ReasonForChange></ReasonForChange>
							<SourceID></SourceID>
							<UserRef UserOID=""/>
							<LocationRef LocationOID=""/>
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					<ReasonForChange></ReasonForChange>
					<SourceID></SourceID>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
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				<Signature ID="">
					<SignatureRef SignatureOID=""/>
					<DateTimeStamp></DateTimeStamp>
					<UserRef UserOID=""/>
					<LocationRef LocationOID=""/>
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				<Annotation SeqNum="" TransactionType="" ID="">
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						<TranslatedText xml:lang="" type=""></TranslatedText>
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					<Comment SponsorOrSite=""> 
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						<FlagType CodeListOID=""/>
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				</Annotation>	
				<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
					<Value SeqNum=""></Value>
					<AuditRecord EditPoint="" UsedMethod="">
						<DateTimeStamp></DateTimeStamp>
						<ReasonForChange></ReasonForChange>
						<SourceID></SourceID>
						<UserRef UserOID=""/>
						<LocationRef LocationOID=""/>
					</AuditRecord>
				</Query>	
			</StudyEventData>
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		<Query OID="" Source="" Target="" Type="" LastUpdateDatetime="" Name="">
			<Value SeqNum=""></Value>
			<AuditRecord EditPoint="" UsedMethod="">
				<DateTimeStamp></DateTimeStamp>
				<ReasonForChange></ReasonForChange>
				<SourceID></SourceID>
				<UserRef UserOID=""/>
				<LocationRef LocationOID=""/>
			</AuditRecord>
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	<Association StudyOID="" MetaDataVersionOID="">
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	<ds:Signature xmlns="http://www.w3.org/2000/09/xmldsig#" Id="1">
		<SignedInfo></SignedInfo>
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		<KeyInfo></KeyInfo>
		<Object></Object>
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                    <FlagValue CodeListOID=""/>
                    <FlagType CodeListOID=""/>
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            <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
                <Value SeqNum=""/>
                <AuditRecord EditPoint="" UsedMethod="">
                    <UserRef UserOID=""> </UserRef>
                    <LocationRef LocationOID=""> </LocationRef>
                    <DateTimeStamp/>
                    <ReasonForChange/>
                    <SourceID/>
                </AuditRecord>
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        </ItemGroupData>
        <AuditRecord EditPoint="" UsedMethod="">
            <UserRef UserOID=""> </UserRef>
            <LocationRef LocationOID=""> </LocationRef>
            <DateTimeStamp/>
            <ReasonForChange/>
            <SourceID/>
        </AuditRecord>
        <Signature ID="">
            <UserRef UserOID=""> </UserRef>
            <LocationRef LocationOID=""> </LocationRef>
            <SignatureRef SignatureOID=""> </SignatureRef>
            <DateTimeStamp/>
        </Signature>
        <Annotation SeqNum="" TransactionType="" ID="">
            <Comment SponsorOrSite="">
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Comment>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            <Flag>
                <FlagValue CodeListOID=""/>
                <FlagType CodeListOID=""/>
            </Flag>
        </Annotation>
        <Query OID="" Source="" Target="" Type="" State="" LastUpdateDatetime="" Name="">
            <Value SeqNum=""/>
            <AuditRecord EditPoint="" UsedMethod="">
                <UserRef UserOID=""> </UserRef>
                <LocationRef LocationOID=""> </LocationRef>
                <DateTimeStamp/>
                <ReasonForChange/>
                <SourceID/>
            </AuditRecord>
        </Query>
    </ClinicalData>
    <Association StudyOID="" MetaDataVersionOID="">
        <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
            StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
        <KeySet StudyOID="" SubjectKey="" MetaDataVersionOID="" StudyEventOID=""
            StudyEventRepeatKey="" ItemGroupOID="" ItemGroupRepeatKey="" ItemOID=""> </KeySet>
        <Annotation SeqNum="" TransactionType="" ID="">
            <Comment SponsorOrSite="">
                <TranslatedText xml:lang="" Type="">
                    <xhtml:div> </xhtml:div>
                </TranslatedText>
            </Comment>
            <Coding Code="" System="" SystemName="" SystemVersion="" Label="" href="" ref="" CommentOID=""> </Coding>
            <Flag>
                <FlagValue CodeListOID=""/>
                <FlagType CodeListOID=""/>
            </Flag>
        </Annotation>
    </Association>
</ODM>